Ortho-Clinical Diagnostics
Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793
| Date | Feb 21, 2003 (initiated Jan 10, 2003) |
| Status | Terminated |
| Reason | Label printing irregularities on cartons and/or bottles. |
| Root cause | Other |
| Action | Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print. |
| Quantity | 284 cartons/2 bottles per carton |
| Distribution | Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) Johnson & Johnson Clinical Diagnostics, Inc., Nov 27, 1996 |